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CTRI Number  CTRI/2021/01/030741 [Registered on: 25/01/2021] Trial Registered Prospectively
Last Modified On: 22/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Finding out effects of neck spine surgery for control of blood pressure in-patients whose blood pressure was high before surgery. 
Scientific Title of Study   Association of cervical spondylotic myelopathy and perioperative hypertension- A retrospectivee study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrManisha Katikar 
Designation  Consultant Anesthesiologist and Intensivist 
Affiliation  Balwant Institute of neurosurgery and intensive trauma care 
Address  Department of anaesthesia Balwant Institute of neurosurgery and intensive trauma care, 111, Modikhana, sat rasta, Solapur
Department of anaesthesia, Balwant Institute of neurosurgery and intensive trauma care, 111, Modikhana, Sat Rasta, Solapur 413001
Solapur
MAHARASHTRA
413001
India 
Phone  09822196824  
Fax    
Email  mdkatikar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrManisha Katikar 
Designation  Consultant Anesthesiologist and Intensivist 
Affiliation  Balwant Institute of neurosurgery and intensive trauma care 
Address  Department of anaesthesia Balwant Institute of neurosurgery and intensive trauma care 111 Modikhana sat Rasta Solapur
Department of anaesthesia Balwant Institute of neurosurgery and intensive trauma care 111 Modikhana sat Rasta Solapur413001
Solapur
MAHARASHTRA
413001
India 
Phone  09822196824  
Fax    
Email  mdkatikar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrManisha Katikar 
Designation  Consultant Anesthesiologist and Intensivist 
Affiliation  Balwant Institute of neurosurgery and intensive trauma care 
Address  Department of anaesthesia Balwant Institute of neurosurgery and intensive trauma care 111 Modikhana sat Rasta Solapur
Department of anaesthesia Balwant Institute of neurosurgery and intensive trauma care 111 Modikhana sat Rasta Solapur 413001
Solapur
MAHARASHTRA
413001
India 
Phone  9822196824  
Fax    
Email  mdkatikar@gmail.com  
 
Source of Monetary or Material Support  
Balwant Institute of neurosurgery and intensive trauma care 
 
Primary Sponsor  
Name  Balwant Institute of neurosurgery and intensive trauma care 
Address  BINIT, 111, Modikhana, sat Rasta, Solapur 413001 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manisha katikar  Ashwini Rural Medical College, Hospital and research centre, Kumbhari  Department of anesthesiology
Solapur
MAHARASHTRA 		 9822196824

mdkatikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee ARMCH&RC, kumbhari, Solapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I159||Secondary hypertension, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients who are admitted for surgery for cervical spondylotic myelopathy due to degenerative cervical spondylotic disease and have hypertension.
2. Hypertension is defined as blood pressure more than 140/90 mmHg 
 
ExclusionCriteria 
Details  1. Patient having cervical myelopathy due to other causes like trauma, infection and neoplasm 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Retrospective data of the patients who underwent decompressive cervical spine surgery will be analysed from patient records
We plan to collect following data from patients records.
1.Blood pressure values at preanesthetic check up, 2.history of hypertension in past,3. antihypertensive medications on which the patient is, 4. preoperative 2D echo finding.5.Post operative blood pressure values on day 1 and day 7. 		 Retrospective data of the patients who underwent decompressive cervical spine surgery will be analysed from patient records
We plan to collect following data from patients records.
1.Blood pressure values at preanesthetic check up, 2.history of hypertension in past,3. antihypertensive medications on which the patient is, 4. preoperative 2D echo finding.5.Post operative blood pressure values on day 1 and day 7. 
 
Secondary Outcome  
Outcome  TimePoints 
Aim of our study is to find out incidence of hypertension in patients with cervical spondylotic myelopathy and percentage of these patients who do not need antihypertensive drugs after decompressive surgery for cervical spondylotic myelopathy  Blood pressure data collected on day 1 and day 7 will be analysed ok 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="25" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 11-01-2021 and end date provided 30-12-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Cervical spondylotic myelopathy is a degenerative disease of spinal cord causing cervical spinal cord compression due to disc bulges, osteophytes,thickened posterior longitudinal ligament and ligamentum flavum. The disease is associated with various neurological symptoms which includes weakness of all four limbs along with numbness and clumsiness of hand. These patients undergo decompressive cervical spinal cord surgery either by anterior approach or posterior approach or combination of both.
Many patients with cervical spondylotic myelopathy have hypertension. They need Pharmacological intervention in the preoperative period to control the blood pressure.
While managing these patient peri-operatively authors realised that a significant number of these patient who were on antihypertensive drugs did not need these drugs after the surgery. Aim of our study is to find out incidence of hypertension in patients with cervical spondylotic myelopathy and percentage of these patients who do not need antihypertensive drugs after decompressive surgery for cervical spondylotic myelopathy
 
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